Use of Acthar in Patients With FSGS That Will be Undergoing Renal Transplantation

Phase 3

Active, not recruiting

• Conditions: FSGS
• Interventions: Drug: Acthar

• Registration Number: NCT02683889
• Lead Sponsor: University of Colorado, Denver

Brief Summary

This study will evaluate the use of Acthar in patients to undergo renal transplantation and will measure the rate of FSGS recurrence.

Detailed Description

This is a prospective study enrolling renal transplant recipients with the primary native kidney disease of FSGS.

Primary endpoint is rate of recurrence of FSGS as seen in renal transplant biopsies and in rate of proteinuria. Secondary endpoint is renal function after transplantation The target subject number is 20 patients and the target population is primary FSGS patients. By the current data, FSGS should recur in 23% of patients. Therefore, it would be expected that at least 4 patients will develop recurrent FSGS after renal transplantation.

Screening will be performed by the Principal Investigator during the kidney transplant evaluation clinics and during the wait list kidney transplant evaluation clinic. All patients with FSGS will have maintenance immunosuppression with belatacept (if EBV positive), prograf, cellcept and prednisone. If after one year the patient has been stable and there has not been rejection, will stop the prograf and continue solely with belatacept, cellcept and prednisone.

Dosage and Administration of Acthar The dose of acthar to be given to every enrolled patient will be 80 units twice a week for 6 months.

Study Timeline

• Study First Submitted: 2016-02-05
• Study First Submitted QC: 2016-02-12
• Study First Posted: 2016-02-17
• Study Start: 2019-02-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-05
• Last Update Posted: 2024-04-08
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• FSGS
• To receive either a live donor or deceased donor kidney transplant

Exclusion Criteria

• Not having FSGS

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
One arm	Acthar	One arm will receive acthar to measure rate of recurrence of FSGS after transplant. There are no other arms. We do have previous data that FSGS recurs in 23% of kidney transplants.

Primary Outcome Measures

Name	Time	Method
Rate of recurrence of FSGS as seen in renal transplant biopsies proteinuria	2 years	This will be studied in the renal transplant biopsies
Rate of recurrence of proteinuria	2 years	By measurement of urine protein and urine creatinine ratio

Secondary Outcome Measures

Name	Time	Method
renal function after transplantation	1 year	By measurement of the estimated glomerular filtration rate with patient's creatinine

Trial Locations

Locations (1)

Medstar Georgetown Transplant Institute; 🇺🇸 Washington, District of Columbia, United States